What New Research Reveals About 18F-flotufolastat PET/CT for Detecting Biochemical Recurrence and Bone Metastasis in PCa

The use of the PET/CT agent ¹⁸F-flotufolastat provides significantly higher detection of biochemical recurrence (BCR) of prostate cancer (PCa) and bone metastases in men with suspected PCa BCR, according to two post-hoc analyses from the SPOTLIGHT trial presented at the American Society of Clinical Oncology Genitourinary Cancers (ASCO-GU) symposium.

In one post-hoc study, researchers compared ¹⁸F-flotufolastat (Posluma, Blue Earth Diagnostics) PET/CT scans in 68 patients (median prostate-specific antigen (PSA) level of 2.22 ng/mL) to conventional imaging in 67 patients (median PSA of 2.10 ng/mL). The study authors noted over a 60 percent higher detection rate (DR) (94-100 percent vs. 33 percent) and a 39 percent higher verified detection rate (VDR) (63 percent vs. 24 percent).¹

“There’s a lot of findings that we would have missed on conventional imaging that … we were able to detect with rhPSMA (radiohybrid PSMA),” noted lead study author Ashesh Jani, M.D., in a recent interview with Diagnostic Imaging.

Dr. Jani, a James C. Kennedy Professor in Prostate Cancer at the Winship Cancer Institute of Emory University, also discussed another post-hoc analysis examining the capability of ¹⁸F-flotufolastat to detect bone metastasis in patients with suspected PCa BCR. Out of 121 patients with a PSA level < 0.5 ng/mL, ¹⁸F-flotufolastat led to detection of bone metastasis in 18 patients for a 15 percent detection rate and a VDR of 9.5 percent.²

“If you see something, you're able to make a diagnosis of a metastasis in the bone at a lower PSA than what we were able to before, but then it even adds the value of a negative test, because it's more reassuring if you don't see something on there. That's more likely to be negative,” posited Dr. Jani.

Dr. Jani noted an ongoing renaissance in molecular imaging with the use of PSMA PET/CT in facilitating improved staging and bolstering subsequent decision-making with respect to BCR in patients with PCa.

“It really is helping us to identify where the source of the PSA is more accurately so we can decide if we need to give just local therapy, if we need to give metastasis-directed therapy at these areas that are outside of the prior treatment, if we need to give a systemic therapy … as opposed to giving something that's more directed. So it is transformative. It really allows us to make improved decisions in the clinical setting, particularly for recurrences,” maintained Dr. Jani, a professor in the Department of Radiation Oncology at the Emory University School of Medicine.

(Editor’s note: For related content, see “Molecular Imaging in Focus: Emerging Insights on the PET and SPECT Imaging Agent 61Cu-NU101 for PCa,” “Comparative Study Shows Merits of PSMA PET/CT for Local Staging of Intermediate and High-Risk PCa” and “Comparing the Urinary Radioactivity of PET Radiotracers: What a Multicenter Study Reveals.”)

References

1. Jani A, Hermsen R, Chau A, Sonecha S.Diagnostic performance of ¹⁸F flotufolastat PET/CT compared with conventional imaging in men with biochemical recurrence of prostate cancer: descriptive post-hoc analysis from the phase 3 SPOTLIGHT study. Presented at the American Society of Clinical Oncology Genitourinary Cancers (ASCO-GU) symposium, February 26-28, 2026, San Francisco.

2. Jani A, Hermsen R, Chau A, Sonecha S. Detection of bone metastases in men with low PSA biochemical recurrence of prostate cancer with ¹⁸F-flotufolastat PET/CT: a post-hoc analysis from the phase 3 SPOTLIGHT study. Presented at the American Society of Clinical Oncology Genitourinary Cancers (ASCO-GU) symposium, February 26-28, 2026, San Francisco.